Claims for Patent: 10,028,910

Summary for Patent: 10,028,910

Title:	Pharmaceutical composition comprising a GLP-1-agonist and methionine
Abstract:	A liquid composition comprising a GLP-1 agonist and/or a pharmacologically tolerable salt thereof and, optionally, at least one pharmaceutically acceptable excipient, wherein the composition comprises methionine, as add-on therapy with metformin and/or with long-acting insulin/insulin derivatives where appropriate.
Inventor(s):	Brunner-Schwarz; Anette (Frankfurt, DE), Mueller; Werner (Frankfurt, DE), Siefke-Henzler; Verena (Frankfurt, DE)
Assignee:	SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE)
Application Number:	15/595,929
Patent Claims:	1. An aqueous liquid pharmaceutical composition comprising the following constituents per 1 mL volume of the composition: (a) approximately 50 .mu.g desPro.sup.36exendin-4(1-39)-Ly.sub.56-NH.sub.2 ("AVE0010") or a pharmacologically tolerable salt thereof; (b) approximately 3.5 mg sodium acetate trihydrate; (c) approximately 2.7 mg m-cresol; (d) approximately 3.0 mg L-methionine; (e) approximately 18.0 mg glycerol; and (f) water, wherein the composition is substantially free of histidine. 2. An aqueous liquid pharmaceutical composition comprising the following constituents per 1 mL volume of the composition: (a) approximately 100 .mu.g desPro.sup.36exendin-4(1-39)-Lys.sub.6-NH.sub.2 ("AVE0010") or a pharmacologically tolerable salt thereof; (b) approximately 3.5 mg sodium acetate trihydrate; (c) approximately 2.7 mg m-cresol; (d) approximately 3.0 mg L-methionine; (e) approximately 18.0 mg glycerol; and (f) water, wherein the composition is substantially free of histidine. 3. The aqueous liquid pharmaceutical composition of claim 1 or 2, wherein the composition further comprises hydrochloric acid, sodium hydroxide, or a combination thereof in an amount sufficient to adjust the pH of the composition to approximately 4.5. 4. The aqueous liquid pharmaceutical composition of claim 1 or 2, wherein the glycerol is 85% glycerol.